Best Drug Stores:
Super Saver Meds Pharmacy 4U New Pharm
Popular Searches:

drugs
viagra
diet pills
drugs prescription drugs weight loss drugs drugs online discount drugs drugstore drugs for depression online drugstore online drugs canadian drugs cheap drugs nc drugs facilities fertility drugs canada drugs brands only drugs acyclovir adipex ambien antibiotic carisoprodol celebrex didrex diet pills discount xenical hydrocodone ionamin lortab meridia online soma paxil penis enlargement phentermine prevacid prilosec propecia prozac renova retin-a senior health soma sonata tenuate tramadol ultram valium valtrex vaniqa viagra vicodin vioxx vitamin wagering weight weight loss wellbutrin women health xanax xenical xenical online zocor zoloft zovirax zyban zyrtec
Other Drugs (W-Z):
Welchol Wellbutrin Westcort Wigraine Winstrol Wygesic Xalatan Xanax Xanax XR Xeloda Xenical Xifaxan Xigris Xolair Xopenex Xylocaine Xylocaine Viscous Xyrem Yasmin Yf-Vax Yocon Zadaxin Zaditor Zagam Zanaflex Zanosar Zantac Zarontin Zavesca Zebeta Zelnorm Zemaira Zemplar Zemuron Zenapax Zenate Prenatal Zerit Zestoretic Zestril Zetia Zevalin Ziac Ziagen Zinacef Zinecard Zithromax Zithromax Zithromax INJ Zocor Zofran Zoladex Zoloft Zometa Zomig Zonegran Zosyn Zotrim Zovia Zovirax Zyban Zyban Zyflo Zyloprim Zyloprim Zyprexa Zyrtec Zyrtec-D Zyvox
A1, A2, B, C1, C2, D, E, F, G-H, I-K, L, M, N, O, P1, P2, Q-R, S, T, U-V, W-Z

Zofran Side Effects, and Drug Interactions - Ondansetron

Zofran Side Effects, and Drug Interactions - Ondansetron

SIDE EFFECTS

INJECTION

Chemotherapy-Induced Nausea and Vomiting

The following adverse events have been reported in individuals receiving ondansetron at a dosage of three 0.15-mg/kg doses or as a single 32 mg dose in clinical trials. These patients were receiving concomitant chemotherapy, primarily cisplatin, and I.V. fluids. Most were receiving a diuretic.

Table 10:
Principal Adverse Events in Comparative Trials

The following have been reported during controlled clinical trials:

Cardiovascular: Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. In many cases, the relationship to ZOFRAN Injection was unclear.

Gastrointestinal: Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron.

Hepatic: In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur.

Integumentary: Rash has occurred in approximately 1% of patients receiving ondansetron.

Neurological: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ZOFRAN Injection, and rare cases of grand mal seizure. The relationship to ZOFRAN was unclear.

Other: Rare cases of hypokalemia have been reported. The relationship to ZOFRAN Injection was unclear.

Postoperative Nausea and Vomiting

The following adverse events have been reported in ³2% of adults receiving ondansetron at a dosage of 4 mg I.V. over 2 to 5 minutes in clinical trials. Rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Table 11:
Adverse Events in ³2% of Adults Receiving Ondansetron at a Dosage of
4 Mg I.V. over 2 to 5 Minutes in Clinical Trials

 
ZOFRAN Injection
4 mg I.V.
n=547
Placebo
n=547
Headache
92( 17 %)
77( 14 %)
Dizziness
67( 12 %)
88( 16 %)
Musculoskeletol Pain
57( 10 %)
59( 11 %)
Drowsiness/Sedation
44( 8 %)
37( 7 %)
Shivers
38( 7 %)
39( 7 %)
Malaise/Fatigue
25( 5 %)
30( 5 %)
Injection Site Reaction
21( 4 %)
18( 3 %)
Urinary Retention
17( 3 %)
15( 3 %)
Postoperative CO2 related pain*
12( 2 %)
16( 3 %)
Chest pain (unspecified)
12( 2 %)
15( 3 %)
Anxiety/Agitation
11( 2 %)
16( 3 %)
Dysuria
11( 2 %)
9( 2 %)
Hypotension
10( 2 %)
12( 2 %)
Fever
10( 2 %)
6( 1 %)
Cold Sensation
9( 2 %)
8( 1 %)
Pruritus
9( 2 %)
3( <1 %)
Paresthesia
9( 2 %)
2( <1 %)

Pediatric Use: The following were the most commonly reported adverse events in pediatric patients receiving ondansetron (a single 0.1 mg/kg dose for pediatric patients weighing 40 kg or less, or 4 mg for pediatric patients weighing more than 40 kg) administered intravenously over at least 30 seconds. Rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Table 12:
Frequency of Adverse Events From Controlled Studies in Pediatric Patients

Adverse Event
Ondansetron
N=755 Patients
Placebo
N=731 Patients
Wound Problem
80( 11 %)
86( 12 %)
Anxiety/Agitation
49( 6 %)
47( 6 %)
Headache
44( 6 %)
43( 6 %)
Drowsiness/Sedation
41( 5 %)
56( 8 %)
Pyrexia
32( 4 %)
41( 6 %)


Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of intravenous formulations of ZOFRAN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ZOFRAN.

Cardiovascular: Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second degree heart block), palpitations, and syncope.

General: Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis, bronchospasm, shortness of breath, hypotension, shock, angioedema, urticaria) have also been reported.

Hepatic: Liver failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.

Local Reactions: Pain, redness, and burning at site of injection.

Neurological: Oculogyric crisis, appearing alone, as well as with other dystonic reactions.

Special Senses: Transient blurred vision, in some cases associated with abnormalities of accommodation, and transient dizziness during or shortly after I.V. infusion.

TABLETS

Chemotherapy-Induced Nausea and Vomiting

The following adverse events have been reported in adults receiving either 8 mg of ZOFRAN Tablets two or three times a day for 3 days or placebo in four trials. These patients were receiving concurrent chemotherapy, primarily cyclophosphamide-based regimens.

Principal Adverse Events in US Trials: 3 Days of Therapy With ZOFRAN Tablets

Event
Ondansetron
8 mg b.i.d.
n=242
Ondansetron
8 mg t.i.d.
n=415
Placebo
n=262
Headache
58( 24%)
113( 27%)
34(13 %)
Malaise/fatigue
32( 13%)
37( 9%)
6( 2%)
Constipation
22( 9%)
26( 6%)
1(< 1%)
Diarrhea
15( 6%)
16( 4%)
10( 4%)
Dizziness
13( 5%)
18( 4%)
12( 5%)
Abdominal pain
3( 1%)
13( 3%)
1(< 1%)
Xerostomia
5( 2%)
6( 1%)
1(< 1%)
Weakness
0( 0%)
7( 2%)
1(< 1%)


Central Nervous System: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron.

Hepatic:In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving ZOFRAN Tablets. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes cannot be clearly determined. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.

Integumentary: Rash has occurred in approximately 1% of patients receiving ondansetron.

Other: Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to ZOFRAN was unclear.

Radiation-Induced Nausea and Vomiting

The adverse events reported in patients receiving ZOFRAN Tablets and concurrent radiotherapy were similar to those reported in patients receiving ZOFRAN Tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea.

Postoperative Nausea and Vomiting

The following adverse events have been reported in ³5% of patients receiving ZOFRAN Tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.

Frequency of Adverse Events From Controlled Studies with ZOFRAN Tablets

Adverse Event
Ondansetron
n=550
Placebo
n=531
Wound Problem
152( 28%)
162( 31%)
Drowsiness/sedation
112( 20%)
122( 23%)
Headache
49( 9%)
27( 5%)
Hypoxia
49( 9%)
35( 7%)
Pyrexia
45( 8%)
34( 6%)
Dizziness
36( 7%)
34( 6%)
Gynecological disorder
36( 7%)
33( 6%)
Anxiety/agitation
33( 6%)
29( 5%)
Bradycardia
32( 6%)
30( 6%)
Shivers
28( 5%)
30( 6%)
Urinary retention
28( 5%)
18( 3%)
Hypotension
27( 5%)
32( 6%)
Pruritus
27( 5%)
20( 4%)

Preliminary observations in a small number of subjects suggest a higher incidence of headache when ZOFRAN ODT Orally Disintegrating Tablets are taken with water, when compared to without water.

DRUG ABUSE AND DEPENDENCE

Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

DRUG INTERACTIONS

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of ondansetron. On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs. Tumor response to chemotherapy in the P 388 mouse leukemia model is not affected by ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron.

top


Popular Searches:

weight loss
ultram
penis enlargement
hydrocodone
antibiotic